CGM-Based Real-World Data on the Transition from Glargine U100 to U300 in Children and Adolescents with Type 1 Diabetes.

Abstract

This study aimed to compare continuous glucose monitoring (CGM) parameters in children and adolescents with Type 1 diabetes (T1D) who transitioned from glargine U100 to glargine U300 to evaluate efficacy and safety. A total of 52 participants aged 6-18 years using CGM were analyzed before and after transitioning from glargine U100 to glargine U300. For each individual, a 2-week CGM data collection was conducted after optimizing the glargine U100 dose. Participants then switched to glargine U300 at the same dose, with doses adjusted based on CGM graphs every three days. One week after the final dose adjustment, a second 2-week CGM period was recorded. Additionally, nighttime (00:00-08:00) data were analyzed, with glucose fluctuations measured by coefficient of variation (CV) and root mean squared error (RMSE). All parameters were compared between glargine U100 and U300. No significant differences were observed in glucose management indicator (GMI) or time in range (TIR) between glargine U100 and U300. However, glargine U300 was associated with significantly reduced hypoglycemia frequency and duration across 24-hour and nocturnal periods. Lower CV and RMSE values during nighttime further indicated reduced glycemic variability with glargine U300. An average 10% increase in basal insulin dose was required following the transition. The study provides real-world, CGM-based evidence suggesting that glargine U300 offers a safer, more stable option for managing T1D in children, particularly in reducing hypoglycemia. These findings highlight glargine U300's potential advantages in glycemic stability, supporting its use in pediatric diabetes care.